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Biogen and Eisai Announce ADUHELM (aducanumab-avwa) Data Presentations at Alzheimer's Association International Conference 2021

Biogen and Eisai Announce ADUHELM (aducanumab-avwa) Data Presentations at Alzheimer s Association International Conference 2021
- Item-level analysis from EMERGE trial shows consistency in slowing decline across cognitive, functional and behavioral measures in early Alzheimer s disease
- Presentations include an assessment of the correlation between reductions in amyloid beta and other biomarkers of Alzheimer s disease and clinical decline after treatment with ADUHELM
- Presentation on ARIA data from Phase 3 trials provides insights for effective monitoring and management in real-world clinical practice
TOKYO, Jul 27, 2021 - (JCN Newswire) - Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen, as part of its Alzheimer s disease (AD) research portfolio, will contribute four virtual posters that showcase data from its clinical trials with ADUHELM (aducanumab-avwa) injection 100 mg/mL solution at the Alzheimer s Association Internati ....

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Investegate |Biogen Inc. Announcements | Biogen Inc.: Biogen and Eisai Announce FDA's 3-Month Extension of Review Period for the Biologics License Application for Aducanumab

Biogen Inc.
Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab
Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab
The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is June 7, 2021
CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The updated Prescription Drug User Fee Act (PDUFA) action date is June 7, 2021. ....

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